Wednesday, March 30, 2016

You
are cordially invited to the Tobacco Harm Reduction conference. This event will
focus on persons with a mental illness and drug users who smoke tobacco. Dr.
Riccardo Polosa, an internationally recognized expert on tobacco harm
reduction from Italy, will be speaking about his research on smoking among
people with schizophrenia

Monday, March 28, 2016

On its Twitter feed last week, CVS Health informed the public that smoking is no more dangerous than vaping.

Here's the tweet:

"They say e-cigs aren't as bad. They said that about light cigarettes too. Learn the facts about e-cigs from @TobaccoFreeKids & help us #BeTheFirst #tobaccofree gen http://ow.ly/ZUhhR."
Clearly, this statement implies that e-cigarettes are as harmful as tobacco cigarettes, even though they contain no tobacco and involve no combustion, thereby producing no smoke.

The Rest of the Story

Unfortunately, CVS Health has disseminated false information to the public. It is not true that vaping is just as hazardous as smoking. There is abundant scientific evidence that vaping is in fact much, much safer than smoking. Even scientists who are decidedly opponents of vaping acknowledge that fact. Professor Stan Glantz, who is very well-respected in the tobacco control community, has stated unequivocally that electronic cigarettes are much safer than real cigarettes.

Comparing statements that e-cigarettes aren't as harmful as cigarettes to Big Tobacco's historical claims about light cigarettes is fraudulent. Essentially, CVS Health is accusing me of scientific misconduct, since I have published research stating that vaping is not as harmful as smoking. Before making such an insinuation, I would hope that CVS Health has sufficient evidence to back up its claim. However, there is no evidence to back up the claim and there is strong evidence to refute the claim that e-cigarettes are just as harmful as cigarettes.

In fact, Dr. Riccardo Polosa and colleagues recently released a study finding that smokers with asthma who switch to e-cigarettes experience a significant improvement in both their respiratory symptoms and their measured lung function. The authors conclude that switching from smoking to vaping can "reverse harm from tobacco smoking in asthma patients who smoke."

CVS Health appears to attempt to back up its claim by linking to a fact sheet from the Campaign for Tobacco-Free Kids. However, nowhere in the fact sheet does it suggest that e-cigarettes are as harmful as conventional cigarettes. Moreover, the fact sheet makes it clear that the opposite is true, stating that "e-cigarettes could benefit public health if they help significantly reduce the number of people who use conventional cigarettes and die of tobacco-related disease." The Campaign for Tobacco-Free Kids is concerned about the effectiveness of e-cigarettes in helping smokers to quit, not the lack of any health benefit to smokers who do quit using these products.

This deceptive tweet from CVS Health could do significant public health damage. Not only does it undermine the public's appreciation of the health hazards of smoking, but it also may discourage many smokers who might otherwise quit using e-cigarettes from doing so, and it may cause many former smokers who vape to go back to smoking. After all, if vaping is as bad as smoking, then you might as well enjoy the real thing, no?

If the goal is to create a tobacco-free generation, then vaping products may well play a critical role. We are not going to achieve a tobacco-free generation simply by discouraging kids from smoking and encouraging smokers to quit. We've been doing that for decades, and while we've made tremendous progress, there are still 40 million adult smokers in the U.S. and 1.5 million youth smokers. What could make a severe dent in smoking rates is the development of a relatively safe non-tobacco alternative product that could take the place of cigarettes for the millions of people who continue to be addicted to smoking and for the 1.4 million youth who experiment with cigarettes each year.

In other words, with the misinformation that CVS Health is putting out, they are doing more to prevent movement towards a tobacco-free generation than to promote it.

The only thing mitigating the potential harm from this deception is the many responses from vapers who are correcting the claim by noting that vaping is actually much safer than smoking. But it is time for CVS Health itself to issue a retraction and correction.

Wednesday, March 23, 2016

Cited Guidelines by AACR and ASCO Demand Conflict of Interest Disclosures, But Fail to Disclose their Own Conflicts

In a review article published online ahead of print Monday in the Journal of the American Association of Nurse Practitioners, a University of Pennsylvania Nursing School professor makes a number of clinical recommendations regarding communications that nurses should have with patients about tobacco and nicotine use. One of those recommendations is that practitioners should not commend smokers who have successfully quit smoking by switching completely to electronic cigarettes.

The author writes:

"Currently, it is neither advisable for practitioners to recommend e-cigarettes for smoking cessation, nor is it recommended to commend patients for making the switch to e-cigarette use over traditional cigarette smoking (Brandon et al., 2015)."

The article cited to support this recommendation is a joint policy statement issued by the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). In this statement, these organizations emphasize that in any articles regarding e-cigarettes:

"Consistent with best practices, investigators should disclose potential conflicts of interest such as funding received from pharmaceutical, tobacco, and ENDS industry sources."

The Rest of the Story

Imagine that I, as a physician making recommendations about the treatment of high blood pressure, issued a recommendation to my fellow physicians that they not commend any patients who successfully get their blood pressure under control using an exercise routine and dietary restrictions. In lieu of commending these patients, what I am really suggesting is that physicians scold their patients for successfully lowering their blood pressure. Not only would this be a ridiculous recommendation, but it would at least border on public health malpractice, since scolding patients for lowering their blood pressure violates any medical standard of care and will likely cause damage by discouraging those patients from continuing to control their blood pressure through diet and exercise.

Unfortunately, the recommendation made by the nursing professor in this article is essentially the same thing. She is essentially telling nurses to scold patients who successfully quit smoking using electronic cigarettes. This is ridiculous, and may represent public health malpractice, since scolding patients for quitting smoking violates any
nursing standard of care and will likely cause damage by discouraging
those patients from continuing to avoid smoking by using vaping products instead.

The article also seems to criticize e-cigarette users for having the perception that vaping is safer than smoking. For example, the author writes:

"The majority of adult e-cigarette users studied in the nine research articles in this review perceived that e-cigarettes contain less toxins than traditional cigarettes. This could be because of the marketing strategies that label e-cigarettes as “healthy,” or the fact that they come in a variety of flavors."

Well, there's another possible reason for this perception: namely, that e-cigarettes do contain fewer toxins than traditional cigarettes.

The author implies that this is an incorrect or even dangerous perception, but this "perception" is absolutely true.

Can you imagine someone writing that: "Many people have the perception that exercise and dietary changes can precipitate weight loss." Would you not agree that such a statement implies that this perception is incorrect? It is not just a perception, it is the truth. The same is true about the "perception" that e-cigarettes contain fewer toxins than traditional cigarettes. It is not "perception"; it is the truth.

It would be one thing if the author merely recommended that e-cigarettes not be used as first-line therapy. But to actually counsel health practitioners not to commend patients who quit smoking - regardless of how they quit - reveals much about the state of the current tobacco control movement.

It reveals that what is now most important is not saving the lives of smokers, but controlling them. The goal is apparently not to protect the health of smokers, but to make them comply with our ideology of no addiction to nicotine being allowed. It's not enough for smokers to quit; they have to quit the way we tell them to quit. And since we weren't the ones who came up with the great idea of vaping products, it is not acceptable for smokers to use that method to quit. It is either our way, or no way. If they don't quit using our methods, then we can't take credit for it. And apparently, credit is more important than health right now.

Now to the joint policy statement by the AACR and ASCO. The statement recommends that physicians not advise patients to use e-cigarettes to quit smoking. This is unwise and inappropriate advice. But what is even more disturbing is the fact that these organizations make such a big point about the need for disclosure of conflicts of interest. In itself, that's not disturbing. What makes it disturbing is the fact that in this very article, both of the organizations fail to disclose their own conflicts of interest with Big Pharma, which stands to gain significantly if the policy statement's recommendation is followed.

The AACR has received funding from a large number of pharmaceutical companies, including Bayer, Bristol-Myers Squibb, Merck, Jannsen, Lilly, Astra Zeneca, GlaxoSmithKline, and Pfizer.

Similarly, the ASCO has received funding from a large number of pharmaceutical companies, including Novartis, Astra Zeneca, GlaxoSmithKline, Onyx, Lilly, Sanofi, Bayer, and Pfizer.

I guess that the need for disclosure of conflicts of interest that AACR and ASCO emphasize only applies to other organizations, not to them.

Tuesday, March 15, 2016

In a video posted at the Huffington Post, Dr. Margaret Cuomo - a physician, author, health blogger, and anti-cancer activist (daughter of former New York governor Mario Cuomo) - declares that electronic cigarettes are "just as dangerous as tobacco cigarettes."

In the video, Dr. Cuomo claims that: "E-cigarettes will raise your risk for lung cancer but also other cancers, like liver cancer." She also states that electronic cigarettes are "at least as harmful to your health as regular tobacco cigarettes are." In addition, she claims that e-cigarette vapor contains many dangerous chemicals that are not found in cigarette smoke, including formaldehyde, benzene, propylene glycol, and metals like cadmium and nickel.

The Rest of the Story

Ironically, this video is characteristic of the lies and deception about the hazards of smoking that the tobacco industry of old used to disseminate to the public. The three major claims that Dr. Cuomo makes are either: (1) completely unsupported by scientific evidence; (2) contradicted by scientific evidence; or (3) an outright lie.

Here is my analysis of the claims:

1. E-cigarettes will raise your risk for lung cancer but also other cancers, like liver cancer.

There is absolutely no evidence to support this claim. E-cigarettes have not been shown to increase the risk of lung cancer, or any cancers for that matter. It is not even clear where the purported link with liver cancer comes from. Even cigarette smoking has not been documented as a direct cause of liver cancer (although it raises the risk of developing liver cancer in patients who have hepatitis B or C).This claim is unsupported by scientific evidence.

2. Electronic cigarettes are just as dangerous as tobacco cigarettes.

This claim is strongly refuted by a multitude of scientific evidence. The levels of carcinogens in e-cigarettes are orders of magnitude lower than in tobacco cigarettes. These products contain no tobacco and involve no combustion. The levels of diacetyl are about 750 times lower than in cigarettes. The levels of tobacco-specific nitrosamines are more than 1000 times lower than in cigarettes. Switching from smoking to vaping has been shown to produce immediate improvement in respiratory symptoms and lung function, to improve asthma symptoms in asthmatic smokers, and to reduce systolic blood pressure in patients with hypertension.

3. E-cigarette vapor contains many dangerous chemicals that are not found
in cigarette smoke, including formaldehyde, benzene, propylene glycol,
and metals like cadmium and nickel.

This claim is an outright lie because we know that cigarette smoke contains every one of these chemicals: formaldehyde, benzene, propylene glycol (which is used as a humectant added to tobacco), and all both of the metals - cadmium and nickel.

This video from Dr. Cuomo is quite unfortunate because it is likely to mislead many smokers into thinking that electronic cigarettes are just as harmful as smoking. This may deter smokers from switching from smoking to vaping. It also may lead former smokers who have quit using e-cigarettes to return to smoking. Thus, this misinformation is not only undermining the public's appreciation of the severe hazards of smoking but it is also damaging to the public's health.

Perhaps what is most unfortunate about this misinformation is that Dr. Cuomo is a strong advocate for cancer prevention and inadvertently is sending a message that is completely contradictory to her goals. While we all agree that youth should not use any nicotine-containing product, electronic cigarettes have helped hundreds of thousands of smokers to quit. Electronic cigarettes and vaping products have a great potential to prevent cancer by helping many smokers to quit or to cut down greatly on the amount that they smoke.

Where is this misinformation coming from? Over the past few years, I have documented a steady stream of lies and deception coming from e-cigarette opponents, including anti-tobacco groups and tobacco researchers. This campaign of deception is working. Today's story shows just how well it is working.

Monday, March 14, 2016

In what I can only call a bizarre phenomenon, a number of local boards of health in Massachusetts are sacrificing the public's health and protecting youth smoking under the guise of protecting adolescent health. These health boards have declared that flavored tobacco products represent a huge health threat to teens. But rather than banning the flavored cigarettes that are addicting and ultimately killing people, they are taking away the far less harmful electronic cigarettes that have helped many adults quit smoking.

Case in point: Saugus, Massachusetts.

Last week, the Saugus Board of Health voted unanimously to ban the sale of flavored electronic cigarettes, while allowing flavored cigarettes - which are favored by nearly 50% of Saugus youth smokers - to remain available in stores throughout the town.

This means that although every gas station, convenience store, and pharmacy in Saugus will have to take most of their e-cigarettes off the shelves, they will not have to touch the flavored Marlboro, Camel, and Newport cigarettes that are so popular among the youth of Saugus. They will also be able to continue selling the mint and wintergreen smokeless tobacco products that are also popular among Saugus youth.

In other words, the Board of Health is removing from the market products which probably kill no one, while protecting the sale of deadly consumer products that we know are killing hundreds of thousands of Americans each year.

This makes absolutely no sense, and it is boggling to me why a board of health would go to such lengths to protect cigarette and smokeless tobacco sales.

The Rest of the Story

Last Wednesday, the Saugus Board of Health adopted a regulation that purportedly bans the sale of all flavored tobacco products in the town. Although that's not a route that I would choose to go, it at least sounds reasonable if applied equally to all flavored tobacco products sold in the town.

But in a show of hypocrisy, the health board decided not to ban all flavored tobacco products in the town. The board voted to exempt from the ban the flavored tobacco products that are most responsible for harming the health of youth in the town (menthol cigarettes, and to some extent mint and wintergreen smokeless tobacco) and to include in the ban flavored non-tobacco products (e-cigarettes) that have not been associated with any significant adverse health effects among youth, but are helping many adult smokers to quit or cut down substantially on the amount they smoke.

You see, the board exempted from regulation three flavors: menthol, mint, and wintergreen. There is no public health rationale for excluding these three flavors. However, this is an economic rationale. Banning these three flavors would put a significant dent in smoking and smokeless tobacco use. In contrast, banning only flavored cigars and cigarillos will have no appreciable effect on overall tobacco sales, or on the public's health.

But where stores in Saugus will see a substantial loss of sales is in the electronic cigarette category. Now, adults in Saugus who quit smoking using e-cigarettes will find it less convenient to access the vaping products which are maintaining them as former smokers, and many of them will undoubtedly decide to return to smoking, since cigarettes will remain readily available in gas stations, convenience stores, and pharmacies throughout the town.

The director of the Northeast Tobacco Free Community Partnership was quoted as stating: "Where adolescent brains are still developing, nicotine can produce
structural and chemical changes to the brain and can lead to future
alcohol and other drug addiction, panic attacks and things like
depression. My concern is really for the health and
safety of the youth of Saugus."

Baloney! If her concern was really for the health and safety of the youth of Saugus, then certainly she would have insisted that the Board of Health protect youth from the sale of all nicotine products, not just the least harmful ones.
A similar regulation is under consideration by the boards of health in Fitchburg and Leominster, although those laws would apparently allow flavored cigars, cigarillos, and e-cigarettes to be sold in adult-only tobacco retail stores (there are no such stores in Saugus, so in that town, the regulation amounts to a de facto ban on the sale of flavored cigars, cigarillos, and e-cigarettes).

A proponent of the regulations was quoted as stating: "We're pretty much eliminating youth access to flavored products...".

Baloney! Youth will still have access to the most dangerous flavored tobacco product in Fitchburg and Leominster: menthol cigarettes.

It is one thing for a legislative body to compromise the public's health to protect cigarette sales. At least legislative bodies are supposed to take economic factors into consideration. But a board of health is supposed to be primarily protecting the public's health. More importantly, they are expected to actually mean what they say. Neither of those is happening these days in many Massachusetts cities and towns.

The rest of the story is that what these boards of health are essentially telling kids is: "We don't care if you use flavored tobacco products, as long as you are using the most deadly and toxic flavored products. We just don't want you to use mildly risky flavored tobacco products. If you use a flavored tobacco product, we want to make sure that it's actually going to kill you, or at least cause substantial health damage."

Monday, March 07, 2016

New legislation being proposed in the state of Massachusetts and in Erie County (New York) would tell pharmacies that they can no longer sell one of the most popular smoking cessation products that they currently offer: electronic cigarettes.

Both bills purport to ensure that pharmacies do not sell unhealthy tobacco products that are inconsistent with their health mission. However, both bills define tobacco products in such a way that they include electronic cigarettes. Thus, pharmacies in Massachusetts and Erie County could no longer sell e-cigarettes to smokers trying to quit if this legislation is enacted.

The Massachusetts legislation (Senate Bill 2152) bans the sale of "tobacco products" in pharmacies. However, it defines tobacco products as:

"any product containing, made, or derived from tobacco or nicotine that is intended for human consumption, whether smoked, chewed, absorbed, dissolved, inhaled, snorted, sniffed, or ingested by any other means, including, but not limited to: cigarettes, cigars, little cigars, chewing tobacco, pipe tobacco, and snuff, or electronic cigarettes, electronic cigars, electronic pipes, or other similar products that rely on vaporization or aerosolization. Tobacco product” includes any component, part, or accessory of a tobacco product. “Tobacco product” does not include any product that has been approved by the United States Food and Drug Administration for sale as a tobacco cessation product and is being marketed and sold solely for the approved purpose."

While the Erie legislation is yet to be introduced, it will define tobacco products in a similar manner as in Massachusetts and will include electronic cigarettes.

The Rest of the Story

Putting aside for a moment the issue of whether there is a valid justification for the government telling pharmacies that they cannot sell tobacco products because selling those unhealthy products is inconsistent with their mission, what justification is there for the government to tell pharmacies that they cannot sell a product that is designed and intended to help smokers quit?

Certainly, getting smokers to quit or to cut down substantially on their cigarette consumption by switching to a much safer product that contains no tobacco (i.e., electronic cigarettes) is a legitimate health objective that is entirely consistent with the mission of pharmacies.

While the sale of electronic cigarettes to youth could be viewed as detrimental to the public's health, the Massachusetts legislation would ban the sale of all tobacco products and electronic cigarettes to anyone less than 21 years of age. Thus, what the legislation is actually banning is the sale of electronic cigarettes to adult smokers.

Essentially, the legislation is helping to promote continued smoking among adults by making it more difficult for them to purchase electronic cigarettes. This makes absolutely no sense.

At very least, both pieces of legislation should be amended to allow the sale of electronic cigarettes, which are not properly or appropriately defined as tobacco products, but are actually tobacco-free products intended to deter tobacco use.

But there is a more fundamental problem here. If these legislators feel comfortable telling pharmacies they cannot sell tobacco products, then what justification is there for these very same legislators to allow gas stations, convenience stores, grocery stores, and supermarkets to sell cigarettes? The justification that the legislature is using to ban the sale of cigarettes in pharmacies - that it is not consistent with their mission - is also true for these other stores. After all, is there any store whose mission is to kill people? The sale of cigarettes is not consistent with the mission of any type of store, not just pharmacies.

So why are these legislators not courageous enough to simply ban the sale of tobacco products, period?

I think it's quite simple. Banning the sale of tobacco products in all stores in a state or a county would actually have an effect on reducing the consumption of cigarettes and would actually protect the public's health by reducing cigarette sales. But banning the sale of tobacco products just in pharmacies will have no appreciable effect on tobacco sales, since people can simply purchase these products in other stores. The appearance is that these legislators do not want to do anything that will actually put a significant dent in cigarette consumption because their state or county would lose tobacco tax revenues and Master Settlement Agreement funding.

What is most disappointing to me is that these legislators are not willing to stand up for a public health principle that they claim to espouse. They are willing to pretend to stand up for this principle only to the point of passing window dressing legislation that does little, if anything, to alleviate the tobacco epidemic. And to make matters worse, this legislation bans the sale of a product that is helping millions of smokers to stay away from toxic tobacco cigarettes.

Tuesday, March 01, 2016

The FDA bears responsibility for the growing number of severe injuries occurring as a result of exploding e-cigarette batteries because rather than acting quickly to regulate e-cigarette safety, the agency dragged its feet, wasting its time in creating a bureaucratic nightmare based on prohibitively expensive product applications that do nothing to directly protect the public's health.

The problem of exploding e-cigarette batteries appears to be a growing one, and these explosions are resulting in severe, often debilitating injuries. While most of the explosions have occurred while the batteries were charging, some have occurred when the batteries were simply being stored or carried. And while some explosions resulted from improper use of the devices, at least several have involved conditions of normal product use.

Fortunately, much is known about the cause of these explosions and about safety standards that can be imposed to greatly reduce the risk. It appears that lithium-ion batteries are somewhat prone to explosion due to the possibility of thermal runaway. To reduce this risk, there are a number of safety precautions, which include overcharge protection, circuit protection (the inclusion of an approved safety circuit), high quality materials, and manufacture only by approved battery pack assemblers. In addition, more prominent and specific warnings and instructions can be provided.

Once the FDA made the decision to assert regulatory jurisdiction over electronic cigarettes, it should have immediately promulgated battery standards to greatly reduce the risk of lithium ion battery explosion. Instead, it has wasted several years crafting an absolutely absurd system of bureaucratic fanagling that will divert much needed resources into reviewing thousands of thousand-page applications and away from actually protecting the health of the public.

Instead of creating a regulatory scheme based entirely on the review of expensive, complex, and burdensome applications that will tie up agency personnel for years, the FDA should instead have simply directly promulgated a set of safety standards for electronic cigarettes. This could have been done many months ago, and we could have put the problem of exploding batteries to rest. Instead, a significant number of vapers are suffering from severe burns from battery explosions that the agency regulating this product has done absolutely nothing to prevent. This is why the FDA bears some responsibility for this unacceptable safety problem.

Were I directing the agency, I would put forward standards for e-cigarette battery safety tomorrow. Standards for temperature regulation, limits on the levels of certain chemicals and flavorings in e-vapor, quality control procedures, and e-liquid manufacturing standards would quickly follow. There would be no bureaucratic requirements for every company to submit burdensome and expensive applications for each stock keeping unit (SKU); instead, they would simply have to document that they are in compliance with the promulgated safety standards. This could be done quickly, without controversy, and without tie-ups in the Office of Management and Budget because of severe adverse effects on small businesses.

Instead, the FDA has gone down the wrong path. It is committed to using the most wasteful and non-productive bureaucratic approach that has no relevance for non-tobacco products and is eschewing the only type of regulation that makes sense for consumer products that are not cigarettes: direct safety regulation.

As a result, significant numbers of vapers are suffering severe and sometimes debilitating injuries.

This has got to stop.

And there's only two entities that can stop it. First, the OMB, by rejecting the current regulations and telling the FDA to put forward some actual safety regulations. Second, the Congress, by creating a sensible statutory framework for the regulation of electronic cigarettes that forces the FDA to put forward some actual safety regulations.

The FDA is so committed to treating vaping products like deadly cigarettes rather than as a much safer consumer product that it is costing people a great deal of unnecessary suffering. No 17-year-old should have to suffer third-degree burns because the agency that claims to want to protect people from the potential hazards of e-cigarettes is so out of touch with reality that they are unable to recognize that regulating vaping products like deadly cigarettes makes absolutely no sense.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.